From: TSS()Subject: Antibiotics in Feed Becoming a Concern (IT'S BEEN A CONCERN...TSS)Date: June 3, 2005 at 1:10 pm PST

Antibiotics in Feed Becoming a Concern

06/02/05 11:20

OMAHA (DTN) -- American agriculture uses about seven times the amount of antibiotics in livestock feed as is used in human medicine every year, according to a news release from Environmental Defense.

People living in areas where antibiotics are heavily used are at greater risk of developing antibiotic-resistant infections, according to Ellen Silbergeld, professor of environmental health services at Johns Hopkins Bloomberg School of Public Health, who was quoted in the release.

Most of the antibiotics in feed, 90 percent, are used in 23 states. Two states, Iowa and North Carolina, each use about 3 million pounds annually, equal to that used by humans nationwide.

The report, Resistant Bugs and Antibiotic Drugs: Local Estimates of Antibiotics in Agricultural Feed and Animal Waste, is the first study to provide state and county level estimates of the quantities of antibiotics used as feed additives for chicken, hogs and beef cattle, along with estimates for antibiotics in animal waste. The report is available at http://www.environmentaldefense.org/go/antibiotic.estimates.

At least one million pounds of antibiotics are estimated to be used as feed additives annually in seven states: Georgia, Arkansas, Texas, Alabama, Minnesota, Mississippi and Missouri. On a per square mile-adjusted basis, Delaware is estimated to be by far the most intensive user of all antibiotic feed additives, using three times as many antibiotics per thousand square miles (187,000 pounds) as the next closest state, North Carolina (64,000 pounds).

Two other smaller states join the ranks of the top 10 states on a per square mile basis, Maryland (4th) and Indiana (9th).

The Environmental Defense report estimates were prepared using new data from the U.S. Department of Agriculture on numbers of animals per county, and multiplying those figures by estimates previously developed by the Union of Concerned Scientists on the quantity of feed-additive antibiotics consumed per animal. UCS presented national estimates, but not state or county estimates.

"The public has a right to know where antibiotics are being used for nonessential purposes, notably as antibiotic feed additives," said Environmental Defense senior attorney Karen Florini, co-author of the report. "Unfortunately, no governmental data are available on quantities of antibiotics used in livestock feed either locally or nationally."

Overuse of antibiotics in agriculture is widely regarded as contributing to the spread of antibiotic-resistant bacteria that threaten human health. Antibiotics are added to feed not to treat sick animals, but rather on the grounds that they may promote slightly faster growth or prevent disease that could result from the crowded, stressful conditions.

"Feeding antibiotics to animals is not only a major cause of antibiotic-resistant bacteria in the human food supply, but also results in the presence of antibiotic-resistant bacteria in animals and in their waste," said Environmental Defense senior scientist Rebecca Goldburg, Ph.D., co-author of the report.

"Those bacteria can in turn colonize and infect farm workers, as well as contaminate water, air, and soil. "With antibiotics, the more you use them, the faster you lose them," concluded Goldburg. "That's because bacteria become resistant in response to being exposed to antibiotics. Antibiotic resistance is a serious and growing threat to human health, so it's just plain foolish to be feeding vast quantities of antibiotics to chickens, pigs, and beef cattle."

The report urges swift enactment of bipartisan federal legislation to phase out use of medically important antibiotics as feed additives, The Preservation of Antibiotics for Medical Treatment Act (S. 742/H.R. 2562), sponsored by U.S. Senator Olympia Snowe, R-Maine and U.S. Rep. Sherrod Brown, D-Ohio.

The bipartisan Senate version of this bill authorizes funds to farmers to help defray costs of phasing out non-therapeutic use of medically important antibiotics, and provides for research and demonstration projects to assist farmers in this transition.

More than 380 organizations, including the American Medical Association, American Academy of Pediatrics, and American Public Health Association, endorsed nearly identical legislation last year.

In April, Environmental Defense, American Academy of Pediatrics, American Public Health Association, Food Animal Concerns Trust and Union of Concerned Scientists filed a formal Citizen Petition with the Food and Drug Administration urging the agency to ban seven classes of medically important antibiotics from use as feed additives, and documenting that those uses violate FDA's specific safety standards for antibiotic use.

agdayta.com

Groups debate US plan on antibiotics for animals

USA: October 4, 2002

WASHINGTON - U.S. proposals aimed at protecting people from antibiotic resistance may limit options for livestock producers trying to keep animals healthy for the food supply, industry groups said.

Consumer groups, meanwhile, said they were encouraged that the Food and Drug Administration was moving to address a serious public health issue by recommending that makers of animal drugs evaluate whether the medicines will lead to people acquiring tough-to-treat infections from food.

"The problem is how does FDA do its job of being concerned about antibiotic resistance, yet at the same time not severely damage or even destroy the industry that produces these antibiotics," Deputy FDA Commissioner Lester Crawford said at a public hearing on the issue.

"I think the balance we are presenting today is well-crafted," Crawford added.

The FDA plan "is a great step forward. The agency actually is taking a stand on the use of antibiotics in animal agriculture," said John Balbus of Environmental Defense, which is a member of Keep Antibiotics Working, a coalition aiming to eliminate inappropriate use of antibiotics in farm animals.

Balbus said he is worried, though, about how quickly the FDA will act on its plan and whether the agency will have enough funding to carry it out. The coalition believes legislation to restrict some current uses of antibiotics in animals is the best way to address the problem, he said.

After repeated exposure to antibiotics, bacteria may learn to outsmart them. In a proposal unveiled last month, the FDA said it wants information about resistance risk when companies apply for approval of an animal drug. Based on the information, the agency may deny approval or restrict use.

Livestock producers and makers of animal drugs said the plan will make it harder to win approval for new medicines.

Barb Determan, a pork producer from Iowa, said she was worried that farmers and veterinarians may be prohibited from using medicines for uses that are not FDA-approved.

"We just want to make sure we have the thing that works right on our animals for keeping them healthy," she said.

Rich Carnevale, a vice president for the Animal Health Institute, said the FDA's current proposal "will overestimate the risk of many compounds and uses." The Animal Health Institute represents Pfizer Inc. , Bayer Corp. and other makers of animal drugs.

Story by Lisa Richwine

REUTERS NEWS SERVICE

http://www.planetark.org/dailynewsstory.cfm/newsid/18040/story.htm

greetings,

is something wrong with this picture here?

snip...

Barb Determan, a pork producer from Iowa, said she was worried that farmers and veterinarians may be prohibited from using medicines for uses that are not FDA-approved.

"We just want to make sure we have the thing that works right on our animals for keeping them healthy," she said.

snip...

by all means, to hell with the humans, just make sure the pigsare fat full of hormones and antibiotics and medicines notapproved by FDA $$$

why is the FDA even there? they have very little power?

a trip last year to Methodist Hospital in Houston, Texas, andmy third neck surgery, i went in well intending to take allprecautions due to the risk of TSEs/CJDs in the hospital arena.i refused cadaver bone for my neck, and refused blood(which caused a stink, no where on the surgery work-up sheetswas any questions relating to human TSEs, and no one seemedto care). at any rate, a veteran of sorts with neck surgeries,and taking all precautions for the surgery from TSEs, andprepared for anything (i thought). They even used some disposabletools due to the potential risk of TSE due to my Mothers death.Four days after surgery i was home on the road to recovery,with my cervical spine all fused at c4-5, c5-6, and c6-7,with a titanium plate screwed at 6 places on 3 levels.Surgery on Nov. 30, and by the 11th or 12th of Dec. i startedgetting sick, just did not feel right. where they took the bonefrom my hip, started to itch, really bad (mom always said itching,meant heeling?), the area started turning reddish, then the areajust blew up, and swelled really fast. Started running a temp.that kept getting higher. Finally called the Emergency roomon a Sat. Spoke with a neurosurgeon that said to get to thehospital immediately. had to wait two days, due to the infectionbeing so severe, before they could even operate. before surgery,the area had become so swollen, (area where they took the bonefrom my hip for my neck), if finally came to a head by monday.my neurosurgeon walked in and saw it, pushed on the area, andgot about 8 OZ. of fluid right there in the hospital room.he simply smelled of it, and said Terry, i think this is astaph infection, of all people, i'm sorry. now when the infectioncontrol team came in, it was a different story. they said it couldbe a hundred of things, and did not want to speak of staph at thattime. 2 days later they came in and confirmed staph. another dayor two they confirmed MRSA. Then went back in, did a completewash-out of the area, took a lot more bone out of my hip(infection had gotten into the bone), and several days later,was then fitted with a 'long-line PIC', shooting 1000 mgs.of VANCOMYCIN to my heart twice a day. was sent home withPIC in place, and boxes and boxes of VANCOMYCIN. i would sayabout in the 2nd or 3rd week, the blood work showed theVanco. was not doing it's job properly, so they then uppedmy dose to 1250 mgs, twice a day, that seemed to hold up untilafter 6 or 7 weeks of this Vanco. they stopped the treatmentand said my blood work looked good. after being released,and never having my questions answered of whether or not theMRSA was gone, or would it come back, or will the Vanco. worknext time, if there is a next time, could i transmit to wife,i was sent home with some extreme pain in my chest, to this day,still having them, but not nearly to the extent as then. So, iguess i am cured? but no one could answer that? i have had allmy neck surgeries at Methodist, and with the same Neurosurgeon.but once you get a hospital staph infection, and then have todeal with their hospital infection control, you are completelyout of the hands of your doctor/neurosurgeon, and in the handsof the hospital infection control team, and it just seemed likei was going to the _company doctor_, so to speak. My insurancecompany had to pay for all this, that the hospital (in my opinion)was responsible for the infection control 'failure'. but whatcaused me to become resistant, and many people around the globe(in my opinion), can go in-directly to the cattle industry, pumpingso much antibiotics and hormones into cattle because they are sosick when going to slaughter. This can be well documented at theFDA warning letters site, under medicated/adulterated tissues.i will post a few examples;

snip...

On or about October 26, 2001, you sold a cow (identified as cow #485 in your

records) for slaughter as human food to [redacted]. USDA analysis oftissue samples collected from that animal identified the presence ofpenicillin at 1.11 ppm in the kidney. A tolerance of 0.05 ppm has beenestablished for residues of penicillin in the edible tissues of cattle(Title 21, Code of Federal Regulations, Part 556.510). The presence ofthis drug in edible tissue from this animal causes the food to beadulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions thatare so inadequate that diseased animals and/or medicated animals bearingpotentially harmful drug residues are likely to enter the food supply.For example, you lack an adequate system for assuring that animalsmedicated by you have been withheld from slaughter for appropriateperiods of time to permit depletion of potentially hazardous residues ofdrugs from edible tissues. As noted in form FDA-483 issued to you onJanuary 2, 2002, you did not follow the labeled withdrawal time of 10days after treating your cow #485 with penicillin. Foods from animalsheld under such conditions are adulterated within the meaning of Section402(a)(4) of the Act.

You are adulterating the penicillin drug that your firm uses on cowswithin the meaning of Section 50 1 (a)(5) when you fail to use the drugin conformance with its approved labeling. Your use of the drug withoutfollowing the labeled withdrawal period causes the drug to be unsafe to use.

snip...

http://www.fda.gov/foi/warning_letters/g30

more examples;

On or about October 24, 2001, you sold a cow, identified by U.S.Department of Agriculture (USDA) sample number 407433 and back tagnumber 63IW 7890, for slaughter as human food at [redacted], through[redacted]. USDA analysis of tissue samples collected from that cowidentified the presence of 7.12 parts pea-million (PPM) of gentamicin inthe kidney tissue. There is no established tolerance for gentamicin incattle (Title 21, Code of Federal Regulations (21 CFR), 556.300). Thepresence of this

drug in the edible tissue from this animal causes the food to beadulterated.

Our investigation also found that you hold animals under conditions,which are so inadequate that diseased animals and/or medicated animalsbearing potentially harmful drug residues are likely to enter the foodsupply. For example, you lack an adequate system for assuring that drugsare used in a manner not contrary to the directions contained in thelabeling; and for assuring that animals medicated by you have beenwithheld from slaughter for appropriate periods of time to permitdepletion of potentially

hazardous residues of drugs from edible tissues. Foods from animals heldunder such conditions are adulterated.

http://www.fda.gov/foi/warning_letters/g3035d.htm

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=A

medicated feeds (skroll to bottom)

http://www.accessdata.fda.gov/scripts/wlcfm/subject_archive.cfm?FL=M

streptomycin in the kidney;

http://www.fda.gov/foi/warning_letters/m869n.pdf

Twelve years ago, the European Union banned growth hormone use in bothdomestic and imported meat because of worries that these compounds couldhave human health effects.

http://europa.eu.int/abc/doc/off/bull/en/9604/p103109.htm

21 3. PREVALENCE OF ANTIMICROBIAL RESISTANCE IN PATHOGENS FROM HUMANS,ANIMALS AND PLANTS, AND ITS IMPACT ON HEALTH AND PRODUCTIVITY...........................................................................Opinion of the SCAN on the criteria for assessing the safety ofmicro-organisms resistant to antibiotics of human, clinical andveterinary importance

Criteria for assessing the safety of micro-organisms resistant toantibiotics of human, clinical and veterinary importance

http://europa.eu.int/comm/food/fs/sc/ssc/out50_en.pdf

http://europa.eu.int/comm/food/fs/sc/scan/out64_en.pdf

http://www.fda.gov/oc/opacom/hottopics/anti_resist.html

Bovine Embryos and Live Cattle: Imports from North America

The Earl of Caithness asked her Majesty's Government:

When the ban on the importation of embryos and live cattle fromNorth America will be lifted; and [HL3912]

What is the scientific evidence for the imposition of a ban onthe importation of embryos and live cattle from North America. [HL3913]

Lord Whitty: Her Majesty's Government have not imposed a ban on importsof bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation inMay last year laying down rules for the prevention, control anderadication of certain transmissible spongiform encephalopathies (TSEs).The legislation was introduced in response to the recommendations of theOffice International des Epizooties (OIE--the international animal healthorganisation) and advice from the Commission's scientific comittees. Thelegislation (and the transitional measures which came into effect inOctober last year) includes requirement that imports into the EU ofbovine embryos and live cattle must be accompanied by certificationconfirming that the feeding of ruminants with protein derived frommammals has been banned and that the ban has been effectively enforced.Some exporting countries, such as Canada and the USA, are currentlyunable to meet these new requirements.

> STAPH. AUREUS, VISA - UK (ENGLAND)> **********************************> A ProMED-mail post>> ProMED-mail is a program of the> International Society for Infectious Diseases>>> [1] Report of reduced susceptibility isolate> [2] Comments on hospital cleanliness>>> [1]> Date: Fri 17 May 2002 10:06 AM EDT> From: ProMED-mail> Source: BBC news, 17 May 2002 [edited]>>>> [Our thanks to Martha Cosgriff for submitting this article as well. Mod.MPP]>> Tougher superbugs reach England> ----------------------------------------------> Doctors fear that their drug defenses against hospital superbugs are> weakening after a patient was diagnosed with a new strain. Bacteria> resistant to many classes of antibiotics are rife in many UK hospitals.> However, even in the most extreme cases, doctors could turn to the> antibiotic vancomycin to clear the infection [for organisms such as> methicillin-resistant _Staph. aureus_ (MRSA) - Mod.LL].>> In the latest case, the unnamed patient [in an unnamed location - Mod.LL]> developed an infection that had shown a low-level resistance even to this> class of drugs. It is the first such case in England, although there have> been vancomycin-resistant strains uncovered in Scotland, as well as in> France, Japan, and the US. An earlier scare in Bristol involved bacteria> which turned out to have insignificant resistance to the drug.>> The patient involved later died, although the infection is not thought to> have been the cause. Hospital officials believe that no one else in the> building has acquired the bacteria.>> "Superbugs" such as MRSA are thought to cost thousands of lives - and> hundreds of millions of pounds to the NHS each year. Poor hospital hygiene> practices are thought by many to contribute to the problem, and in July> 2000, the government launched a 60-million-pound drive to improve cleanliness.>> However, another key factor is the heavy use of antibiotics, particularly> in the hospital environment. Exposure to these drugs eventually leads to> the survival of strains whose genetic makeup lends itself to drug> resistance as weaker, competing strains are killed off. [Many> antimicrobial-susceptible strains are not at all necessarily weaker; in> many cases, the more resistant strain may be a weaker pathogen -Mod.LL].>> Dr Georgia Duckworth, from the Public Health Laboratory Service (PHLS),> which monitors infectious disease in the UK, said: "With the development of> antibiotic resistance, _Staph. aureus_ infections have become harder to> treat as there are fewer antibiotics that are effective. Since the> discovery of MRSA, vancomycin has been the first choice antibiotic used in> its treatment. This first case in England is a serious development.">> Scientists are racing to develop new types of antibiotics as resistant> strains of bacteria render existing drugs increasingly ineffective. New> classes of drugs have been introduced in recent years, but doctors are> still being urged to cut back on antibiotic usage wherever possible to slow> down the arrival of resistance.>> Dr Duckworth said: "It underscores the fact that there is no cause for> complacency in antibiotic usage - whenever we use an antibiotic, even if> totally appropriately, we encourage the development of resistance to it.">> ******> [2]> Date: 17 May 2002> From: ProMED-mail> Source: The Scotsman (UK) [edited]>>>> Hospitals said to be dirtier than abattoirs> ------------------------------------------------> One of Scotland's leading infections experts last night criticized hygiene> in NHS hospitals as being worse than that in slaughterhouses.>> Hugh Pennington, a professor of bacteriology at Aberdeen University, said> abattoirs have better facilities to prevent infection than most hospitals.> But as he spoke Scotland's health service was warned that further> improvements in cleanliness would never eradicate superbugs, and new drugs> would only buy time before they became resistant to those treatments as well.>> Professor James Naismith, from St Andrews University, warned the antibiotic> vancomycin was the last line of defense against MRSA> [(methicillin-resistant _Staph. aureus_)], but the superbug was already> becoming resistant to the drug [at least less sensitive - Mod.LL].>> The scientists' comments followed a survey which revealed that over half of> patients treated in NHS hospitals thought their homes were cleaner than the> wards. Prof Pennington said: "If our hospitals were kept at the level of> cleanliness that slaughterhouses currently observe, it would be a far> better deal for the patients. 10 percent of people who go into hospital> contract an infection while they're in there and all of these infections> are preventable with improved hygiene [at least a goodly number of them -> Mod.LL]. Staff who work in a modern slaughterhouse wash their hands every> 5 minutes. The NHS do not always make it easy for their staff to wash their> hands when they need to. Just having more hand-wash basins and putting> them in the right place could make a huge difference.">> Meanwhile, Prof Naismith issued his warning over superbugs after receiving> a GBP 637 000 grant from the Wellcome Trust for a study of the structure of> vancomycin in an effort to find new ways of fighting MRSA.>> [Byline: Kate Foster and Alastair Dalton]>> --> ProMED-mail>>> [A number of reports of MRSA demonstrating reduced susceptibility to> vancomycin have occurred since 1997 and are noted below. These isolates> called VISA (vancomycin-intermediate _Staph. aureus_) or GISA> (glycopeptide-intermediate _Staph. aureus_) have generally been isolated> from patients who have had prolonged exposure to vancomycin in a hospital> setting. Fortunately, serious life-threatening illness was not usually> associated with this infection, and high doses of vancomycin were still> effective. Many isolates of another organism (Enterococcus), however,> previously uniformly sensitive to vancomycin, have developed high-grade> resistance to the drug. Fortunately, the enterococcus is not always a> significant pathogen in people, but it would be quite problematic if such a> resistance pattern appeared in _Staph. aureus_ or _Strep. pneumoniae_ and> those organisms were virulent. A new antimicrobial, linezolid, does have> activity against the vancomycin-resistant enterococcus and is active> against Staph. as well. However, only time and increasing use are needed> for linezolid-resistant strains of these organisms to become> prevalent. The 2 issues discussed in the reports, overuse of> antimicrobials (especially in the hospital setting) and inadequately> followed infection control procedures, contribute to the development and> spread of resistant strains, respectively.>> Ultimately, it is not likely that we will eradicate such resistant strains,> but judicious use of antimicrobials and aggressive enforcement of> handwashing and other infection control procedures can limit the impact of> these organisms. - Mod.LL]>> [see also:> 1999> ----> Vancomycin resist. S. aureus - China (Hong Kong) (04) 19991109.2008> Staph. Aureus, VISA - UK (Scotland) 19990621.1056> 1998> ----> Staphylococcus aureus, vancomycin res. - USA (New York) 19980426.0791> Vancomycin resistance, intermed., S. aureus - Europe 19980108.0057> 1997> ----> Staph. Aureus, reduced susceptibility to Vancomycin (02) 19970907.1928> Staph. Aureus, vancomycin resistant - USA 19970825.1775]> ...........................ll/pg/mpp>> *##########################################################*> ProMED-mail makes every effort to verify the reports that> are posted, but the accuracy and completeness of the> information, and of any statements or opinions based> thereon, are not guaranteed. The reader assumes all risks in> using information posted or archived by ProMED-mail. ISID> and its associated service providers shall not be held> responsible for errors or omissions or held liable for any> damages incurred as a result of use or reliance upon posted> or archived material.> ************************************************************> Visit ProMED-mail's web site at .===============================================================

more warning letters....tss

Our investigation also found that you hold animals underconditions which are so inadequate that medicated animals bearingpotentially harmful drug residues are likelyto enter the food supply....

SNIP...

http://www.fda.gov/foi/warning_letters/g2075d.pdf

may take some time to load, but worth reading.check all the different antibiotics;

USDA testing revealed the presence of 0.23 ppm(parts per million) penicillin in the kidneytissue of the animal. This is considered to beillegal tissue residue since the tolerance forpenicillin in edible bovine tissue is 0.05 ppm.The presence of penicillin in the edible tissuefrom your animal at the concentration level detectedrenders the food from the animal to be adulteratedunder section blah blah blah....

Staphylococcus aureus is a cause of hospital- and community-acquired infections.1,2 In 1996, the first clinical isolate of S. aureus with reduced susceptibility to vancomycin was reported from Japan.3 The vancomycin minimum inhibitory concentration (MIC) result reported for this isolate was in the intermediate range (vancomycin MIC = 8 µg/mL) using interpretive criteria defined by the National Committee for Clinical Laboratory Standards.4 As of June 2002, eight patients with clinical infections caused by vancomycin-intermediate S. aureus (VISA) have been confirmed in the United States.5,6 This report describes the first documented case of infection caused by vancomycin-resistant S. aureus (VRSA) (vancomycin MIC 32 µg/mL) in a patient in the United States. The emergence of VRSA underscores the need for programs to prevent the spread of antimicrobial-resistant microorganisms and control the use of anti-microbial drugs in health-care settings.

In June 2002, VRSA was isolated from a swab obtained from a catheter exit site from a Michigan resident aged 40 years with diabetes, peripheral vascular disease, and chronic renal failure. The patient received dialysis at an outpatient facility (dialysis center A). Since April 2001, the patient had been treated for chronic foot ulcerations with multiple courses of antimicrobial therapy, some of which included vancomycin. In April 2002, the patient underwent amputation of a gangrenous toe and subsequently developed methicillin-resistant S. aureus bacteremia caused by an infected arteriovenous hemodialysis graft. The infection was treated with vancomycin, rifampin, and removal of the infected graft. In June, the patient developed a suspected catheter exit-site infection, and the temporary dialysis catheter was removed; cultures of the exit site and catheter tip subsequently grew S. aureus resistant to oxacillin (MIC >16 µg/mL) and vancomycin (MIC >128 µg/mL). A week after catheter removal, the exit site appeared healed; however, the patient's chronic foot ulcer appeared infected. VRSA, vancomycin-resistant Enterococcus faecalis (VRE), and Klebsiella oxytoca also were recovered from a culture of the ulcer. Swab cultures of the patient's healed catheter exit site and anterior nares did not grow VRSA. To date, the patient is clinically stable, and the infection is responding to outpatient treatment consisting of aggressive wound care and systemic antimicrobial therapy with trimethroprim/sulfamethoxazole.

The VRSA isolate recovered from the catheter exit site was identified initially at a local hospital laboratory using commercial MIC testing and was confirmed by the Michigan Department of Community Health and CDC. Identification methods used at CDC included traditional biochemical tests and DNA sequence analysis of gyrA and the gene encoding 16S ribosomal RNA. Molecular tests for genes unique to enterococci were negative. The MIC results for vancomycin, teicoplaninin, and oxacillin were >128 µg/mL, 32 µg/mL, and >16 µg/mL, respectively, by the broth microdilution method. The isolate contained the vanA vancomycin resistance gene from enterococci, which is consistent with the glycopeptide MIC profiles. It also contained the oxacillin-resistance gene mecA. The isolate was susceptible to chloramphenicol linezolid, minocycline, quinupristin/dalfopristin, tetracycline, and trimethoprim/sulfamethoxazole.

Epidemiologic and laboratory investigations are under way to assess the risk for transmission of VRSA to other patients, health-care workers, and close family and other contacts. To date, no VRSA transmission has been identified.

Infection-control practices in dialysis center A were assessed; all health-care workers followed standard precautions consistent with CDC guidelines.7 After the identification of VRSA, dialysis center A initiated special precautions on the basis of CDC recommendations,8 including using gloves, gowns, and masks for all contacts with the patient; performing dialysis with a dedicated dialysis machine during the last shift of the day in an area separate from other patients; having a dialysis technician dedicated to providing care for the patient; using dedicated, noncritical patient-care items; and enhancing education of staff members about appropriate infection-control practices. Assessment of infection-control practices in other health-care settings in which the patient was treated is ongoing.

This report describes the first clinical isolate of S. aureus that is fully resistant to vancomycin. S. aureus causes a wide range of human infections and is an important cause of health-care associated infections. The introduction of new classes of antimicrobials usually has been followed by emergence of resistance in S. aureus. After the initial success of penicillin in treating S. aureus infection, penicillin-resistant S. aureus became a major threat in hospitals and nurseries in the 1950s, requiring the use of methicillin and related drugs for treatment of S. aureus infections. In the 1980s, methicillin-resistant S. aureus emerged and became endemic in many hospitals, leading to increasing use of vancomycin. In the late 1990s, cases of VISA were reported.

Although the acquired vancomycin-resistance determinants vanA, vanB, vanD, vanE, vanF, and vanG have been reported from VRE, these resistance determinants have not previously been identified in clinical isolates of S. aureus.9 Conjugative transfer of the vanA gene from enterococci to S. aureus has been demonstrated in vitro.10 The presence of vanA in this VRSA suggests that the resistance determinant might have been acquired through exchange of genetic material from the vancomycin-resistant enterococcus also isolated from the swab culture. This VRSA isolate is susceptible in vitro to several antimicrobial agents, including antimicrobials recently approved by the Food and Drug Administration (i.e., linezolid and quinupristin/dalfopristin) with activity against glycopeptide-resistant Gram-positive microorganisms.

In 1997, the Healthcare Infection Control Practices Advisory Committee published guidelines for the prevention and control of staphylococcal infection associated with reduced susceptibility to vancomycin8; plans to contain VISA/VRSA on the basis of CDC recommendations have been established in some state health departments. In the health-care setting, a patient with VISA/VRSA should be placed in a private room and have dedicated patient-care items. Health-care workers providing care to such patients should follow contact precautions (i.e., wearing gowns, masks, and gloves and using antibacterial soap for hand washing). These control measures were adopted by dialysis center A immediately following confirmation of the VRSA isolate. To date, there has been no documented spread of this microorganism to other patients or health-care workers.

Strategies to improve adherence to current guidelines to prevent transmission of antimicrobial resistant micro-organisms in health-care settings should be a priority for all health-care facilities in the United States. S. aureus should be tested for resistance to vancomycin using a MIC method. The isolation of S. aureus with confirmed or presumptive vancomycin resistance should be reported immediately through state and local health departments to the Division of Healthcare Quality Promotion, National Center for Infectious Diseases, CDC, telephone 800-893-0485.

First case of fully vancomycin-resistant S. aureus infection in the US reported

Last Updated: 2002-07-03 14:34:22 -0400 (Reuters Health)

By Mean Rauscher

NEW YORK (Reuters Health) - The first documented case in the US of infection caused by Staphylococcus aureus that is fully resistant to vancomycin has federal health officials at the Centers for Disease Control and Prevention (CDC) in Atlanta concerned.

In a telebriefing Wednesday, Dr. Steve Solomon, medical epidemiologist at the CDC, said, "this case serves to reinforce the absolute necessity of adhering to strict infection control precautions, as has been done in this case--and to continue to use antibiotics wisely."

Dr. Solomon also said this case represents an evolution in drug resistance in this particular microorganism, which has been going on for 50 years.

The first S. aureus isolate with reduced susceptibility to vancomycin (vancomycin-resistant Staphylococcus aureus, or VRSA) was reported in Japan in 1996, the CDC notes in the Morbidity and Mortality Weekly Report for July 5th. As of June 2002, eight confirmed cases of infections caused by S. aureus isolates with "intermediate" susceptibility to vancomycin have been reported in the US.

The first fully resistant S. aureus infection in the US was confirmed in June. The patient is a 40-year-old Michigan resident with complicated diabetes, peripheral vascular disease, and chronic renal failure for which he receives regular hemodialysis at an outpatient center. The patient had been taking multiple antibiotics, including vancomycin, for chronic foot ulcerations.

In April 2002, he had a gangrenous toe amputated. When he later developed methicillin-resistant S. aureus bacteremia due to an infected hemodialysis graft, his physicians removed the infected graft and he initiated vancomycin and rifampin treatment.

Subsequently, a swab taken from a catheter exit site infection revealed VRSA (MIC >128 µg/mL). The isolate was also resistant to oxacillin (MIC >16 µg/mL). Swabs from the patient's infected chronic foot ulcer also revealed VRSA, as well as vancomycin-resistant Enterococcus faecalis (VRE) and Klebsiella oxytoca.

According to the CDC, the patient responded to aggressive wound care and trimethoprim/sulfamethoxazole. Dr. Solomon said it's "reassuring" that the VRSA isolate was also susceptible to chloramphenicol, linezolid, minocycline, quinupristin/dalfopristin, and tetracycline.

It's also reassuring, Dr. David Johnson, deputy director and chief medical executive for the Michigan Department of Community Health in Lansing, told Reuters Health, that "swab samples from several hundred potential contacts show no evidence that the VRSA isolate has been transmitted."

The CDC recommends that all S. aureus isolates be tested for resistance to vancomycin and those with confirmed or presumptive vancomycin resistance be reported through state and local health departments to the CDC.

Hypotension: Too rapid IV infusion or bolus administration may be associated with exaggerated hypotension, including shock and cardiac arrest, with or without maculopapular rash over face, neck, upper chest, and extremities (Red Man or Redneck syndrome). Reaction has been rarely associated with slow infusion or oral or intraperitoneal administration.

* Prepare oral solution by adding 115 mL of water to 10 g vial or 20 mL of water to 1 g vial. Further dilute prepared oral solution dose with 30 mL of water or flavoring syrups may be used with oral solution.* May give oral solution via nasogastric tube as indicated or ordered.* Reconstitute parenteral form with Sterile Water for Injection.* Further dilute parenteral medication with compatible solution (eg, 5% Dextrose Injection, 0.9% Sodium Chloride, Lactated Ringer's)* Parenteral form may be administered by oral route.* Reconstituted oral solution may be stored in refrigerator for 2 wk after bottle is opened.* Dilute to minimum dilution of 2.5 mL and infuse parenteral solution over at least 60 min. Intermittent infusion preferred.* Pretreat with antihistamine if patient has previously experienced Red Man Syndrome.* Dosage or dosage interval may be changed based upon vancomycin serum levels.* Reconstituted powder for injection is stable at room temperature for 2 wk.* Dilute solutions (sodium chloride or D5W) are stable at room temperature for 24 hr.

Assessment/Interventions:

* Obtain patient history, including drug history and any known allergies.* Assess results of culture and sensitivity to determine sensitivity.* Assess hearing acuity before and after therapy. Anticipate ototoxicity.* Monitor for signs of superinfection.* Monitor skin for Red Man Syndrome with each dose infused.* Notify health care provider of elevated BUN and creatinine, which indicate nephrotoxicity.* Document hematuria and notify health care provider.* Monitor I&O, BP for hypotension, and respirations for wheezing or dyspnea.* Maintain adequate fluid intake.* Obtain blood levels, new order, or protocol. Keep blood levels between 10 to 20 mcg/mL.* Ensure that resuscitation equipment is available.

A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your cattle raising operation. As a follow-up to USDA?s finding, our investigator performed an inspection of your operation located in Rock Valley, Iowa, on March 21 to 25, 2002. The inspection revealed serious violations of Section 402 and 501 of the Federal Food, Drug, and Cosmetic Act (the Act).

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512. On/about February 12, 2002, you offered a cow, identified with back tag number 41 MN 4358 (USDA laboratory report number 442053) for slaughter as human food. USDA analysis of tissue samples collected from that cow identified the presence of the drugs penicillin in the kidney at 0.55 parts per million (ppm), gentamicin in the kidney at 6.09 ppm, and sulfamethazine in the muscle at 6.22 ppm. Presently, the tolerance level for penicillin and sulfamethazine in the edible tissues of cattle is 0.05 ppm and 0.1 ppm respectively. There is no tolerance for gentamicin in the edible tissues of cattle.

A food is adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions.. . whereby it may have been rendered injurious to health." As it applies in the case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, you lack an adequate system for assuring that animals have been treated only with drugs which have been approved for use in those species; for assuring that drugs are used in a manner not contrary to the directions contained in the labeling; and for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

You are adulterating the drugs penicillin, gentamicin and sulfamethazine that you use on cattle within the meaning of Section 501(a)((5) when you fail to use the drugs in conformance with its approved labeling. Your use of the drugs in a species for which it is not approved, at a higher than labeled dosage, or without following labeled withdrawal periods, causes the drugs to be unsafe to use.

This is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal for sale to a slaughter facility where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act.

You should notify our office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Clarence R. Pendleton, Compliance Officer, at the address listed above.